# K172345: IU Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Warantec Co., Ltd.
- Decided: Jun 18, 2018 after 320 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K931767 (1994). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123155: Luna Dental Implant System, Shinhung Mst Co., Ltd. (2013) Summary page 5.

## Most influential descendants
- K221972: Warantec Custom Abutment (2023), 0 descendants of its own
- K221969: IU Implant System Abutment (2023), 0 descendants of its own

## Indications for use
The IU Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

Source page: https://510kreport.com/device/K172345
Methodology: https://510kreport.com/methodology